BUN Reagent

GUDID 00811403011124

For the quantitative determination of urea nitrogen in serum or plasma.

Diamond Diagnostics Inc.

Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator Multiple electrolyte IVD, calibrator

• Primary Device ID: 00811403011124
• NIH Device Record Key: a42e35af-336b-4f31-972b-26b0b8806996
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BUN Reagent
• Version Model Number: BK-443350D
• Company DUNS: 947514303
• Company Name: Diamond Diagnostics Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811403011124 [Primary]

FDA Product Code

• CDS: Electrode, Ion Specific, Urea Nitrogen

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-13
• Device Publish Date: 2023-06-05

On-Brand Devices [BUN Reagent]

• 00811403011124: For the quantitative determination of urea nitrogen in serum or plasma.
• 00811403011650: BK-472482D